Laparoscopic Adjustable Gastric Banding in Adolescents
1 other identifier
interventional
57
1 country
1
Brief Summary
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 23, 2007
CompletedFirst Submitted
Initial submission to the registry
June 7, 2012
CompletedFirst Posted
Study publicly available on registry
June 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2016
CompletedResults Posted
Study results publicly available
June 8, 2023
CompletedAugust 1, 2023
July 1, 2023
9 years
June 7, 2012
March 31, 2023
July 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Weight Loss
Weight loss in kilograms Weight on day of surgery minus last weight recorded before end of trial
Up to five years post surgery.
Secondary Outcomes (1)
Insulin Resistance
Baseline
Study Arms (1)
Gastric Banding
EXPERIMENTALSurgical placement of an adjustable gastric band around the upper portion of the stomach. Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction.
Interventions
Surgical placement of an adjustable gastric band around the upper portion of the stomach. Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction.
Eligibility Criteria
You may qualify if:
- ages 14-19
- BMI \> 35
- history of obesity for at least 5 years with failed attempts at diet and medical management for at least 6 months.
- confirmation by a pediatric psychologist that the subject is sufficiently mature emotionally and has adequate family support to comply with the study protocol.
You may not qualify if:
- history of congenital or acquired anomalies of the GI tract.
- history of esophageal motility disorders
- uncontrolled psychiatric problems
- previous esophageal, gastric or bariatric surgery; intestinal obstruction or peritonitis.
- uncontrolled eating disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kirk Reichardlead
Study Sites (1)
A I duPont Hospital for Children/Nemours Children's Clinic
Wilmington, Delaware, 19803, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kirk W Reichard, MD, MBA, Surgical Director
- Organization
- Nemours Childrens Health Delaware
Study Officials
- PRINCIPAL INVESTIGATOR
Kirk Reichard, MD
A I duPont Hospital for Children; Nemours Children's Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- OR SURGICAL DIRECTOR
Study Record Dates
First Submitted
June 7, 2012
First Posted
June 14, 2012
Study Start
April 23, 2007
Primary Completion
April 4, 2016
Study Completion
April 4, 2016
Last Updated
August 1, 2023
Results First Posted
June 8, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share